Orange Book product · Brand (NDA)
ROWASA
MESALAMINE
At a glance
Dec 24, 1987
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MESALAMINE
Strength
4GM/60ML
Dosage form
ENEMA
Route
RECTAL
TE code
AB
Application
NDA 019618
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2013DELZICOLBrand (NDA)
NDA 204412 · ABBVIE
- 2008APRISOBrand (NDA)
NDA 022301 · SALIX
- 2008ASACOL HDBrand (NDA)
NDA 021830 · ABBVIE
- 2007LIALDABrand (NDA)
NDA 022000 · TAKEDA PHARMS USA
- 2004CANASABrand (NDA)
NDA 021252 · ABBVIE
- 1993PENTASABrand (NDA)
NDA 020049 · TAKEDA PHARMS USA
- 1992ASACOLBrand (NDA)
NDA 019651 · APIL
- 1990ROWASABrand (NDA)
NDA 019919 · MEDA PHARMS
- 2026MESALAMINEGeneric (ANDA)
ANDA 220016 · KLM LABS PVT
- 2026MESALAMINEGeneric (ANDA)
ANDA 219997 · DIFGEN PHARMS
- 2025MESALAMINEGeneric (ANDA)
ANDA 219864 · ANNORA PHARMA
- 2025MESALAMINEGeneric (ANDA)
ANDA 215269 · NOVITIUM PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
